ZYDUS PHARMS USA INC FDA Approval ANDA 077652

ANDA 077652

ZYDUS PHARMS USA INC

FDA Drug Application

Application #077652

Application Sponsors

ANDA 077652ZYDUS PHARMS USA INC

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL250MG0LEVOFLOXACINLEVOFLOXACIN
002TABLET;ORAL500MG0LEVOFLOXACINLEVOFLOXACIN
003TABLET;ORAL750MG0LEVOFLOXACINLEVOFLOXACIN

FDA Submissions

ORIG1AP2012-09-07
LABELING; LabelingSUPPL2AP2014-09-25STANDARD
LABELING; LabelingSUPPL3AP2014-09-25STANDARD
LABELING; LabelingSUPPL8AP2019-04-16STANDARD
LABELING; LabelingSUPPL10AP2019-04-16STANDARD
LABELING; LabelingSUPPL14AP2019-04-16STANDARD
LABELING; LabelingSUPPL15AP2019-04-16STANDARD
LABELING; LabelingSUPPL16AP2019-05-03STANDARD
LABELING; LabelingSUPPL17AP2020-05-29STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL19AP2022-04-04UNKNOWN

Submissions Property Types

ORIG1Null15
SUPPL2Null15
SUPPL3Null15
SUPPL8Null15
SUPPL10Null15
SUPPL14Null15
SUPPL15Null7
SUPPL16Null7
SUPPL17Null15
SUPPL19Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

ZYDUS PHARMS USA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77652
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOFLOXACIN","activeIngredients":"LEVOFLOXACIN","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOFLOXACIN","activeIngredients":"LEVOFLOXACIN","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOFLOXACIN","activeIngredients":"LEVOFLOXACIN","strength":"750MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LEVOFLOXACIN","submission":"LEVOFLOXACIN","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LEVOFLOXACIN","submission":"LEVOFLOXACIN","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LEVOFLOXACIN","submission":"LEVOFLOXACIN","actionType":"750MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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